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BioMerieux SA recalls VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in
Recalled August 13, 2014 · FDA recall Z-2152-2014 · BioMerieux SA
Hazard
Product is not approved or authorized for distribution in the US. · FDA Class II
Units
1902
Sold at
FL, LA, MI, MS, NV, OH, OK, TN, TX
Description
Product is not approved or authorized for distribution in the US.
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Manufacturer(s)
BioMerieux SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →